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Zolvit

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Zolvit

Indications
Dosage
How Supplied

INDICATIONS

ZOLVIT™ is indicated for the relief of moderate to moderately severe pain.

DOSAGE AND ADMINISTRATION

Dosage should be adjusted according to severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

The usual adult dosage is approximately 2 1/4 tea-spoonfuls every 4 to 6 hours as needed for pain. The total daily dosage for adults should not exceed 131/2 teaspoonfuls. The usual dosages for children are given by the table below, and are to be given every 4 to 6 hours as needed for pain. These dosages correspond to an average individual dose of 0.20 mL/kg of ZOLVIT™ (providing 0.135 mg/kg of hydrocodone bitartrate and 4.0 mg/kg of acetaminophen). Dosing should be based on weight whenever possible.

BODY WEIGHT APPROXIMATE AGE DOSE every 4 to 6 hours MAXIMUM TOTAL DAILY DOSE
(6 doses per day)
12 to 15 kg
(27 to 34 Ibs.)
2 to 3 years 2.8 mL
(approx. ½ teaspoonful)
1 6.8 ml
(approx. 31/4 teaspoonfuls)
16 to 22 kg
(35 to 50 Ibs.)
4 to 6 years 3.75 mL
(approx. 3/4 teaspoonful)
22.5 ml
(approx. 4½ teaspoonfuls)
23 to 31 kg
(51 to 69 Ibs.)
7 to 9 years 5.6 mL
(approx. 1 teaspoonful)
33.6 ml
(approx. 6½ teaspoonfuls)
32 to 45 kg
(70 to 100 Ibs.)
10 to13years 7.5 mL
(approx. 1 ½ teaspoonful)
45 ml
(approx. 9 teaspoonfuls)
46 kg and up
(101 Ibs. and up)
1 4 years to adult 11 .25 ml
(approx. 21/4 teaspoonfuls)
67.5 ml
(approx. 13½ teaspoonfuls)

The total daily dosage for children should not exceed 6 doses per day. It is of utmost importance that the dose of ZOLVIT™ be administered accurately. A household teaspoon or tablespoon is not an adequate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured. Given the inexactitude of the household spoon measure and the possibility of using a tablespoon instead of a teaspoon, which could lead to overdosage, it is strongly recommended that care givers obtain and use a calibrated measuring device. Health care providers should recommend a dropper that can measure and deliver the prescribed dose accurately, and instruct care givers to use extreme caution in measuring the dosage.

HOW SUPPLIED

ZOLVIT™ (hydrocodone bitartrate and acetaminophen oral solution) is a red-colored, tropical fruit punch flavored liquid containing hydrocodone bitartrate 10 mg and acetaminophen 300 mg per 15 ml, with 7% alcohol. It is supplied in containers of 16 fl oz (NDC 59702-674-16) and in 1 fl. oz. sample bottles for patient trial available only through physician Offices, NDC 59702-674-15.

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure.

A Schedule CIII Narcotic

Manufactured for: Atley Pharmaceuticals, Inc. Ashland, VA 23005. Manufactured by: Mikart Inc. Atlanta, GA 30 2010 Atley Pharmaceuticals, Inc.

Last reviewed on RxList: 8/15/2011
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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